Efficacy Study of EVT 201 to Treat Insomnia
Phase 2
Completed
- Conditions
- Sleep Initiation and Maintenance Disorders
- Registration Number
- NCT00380003
- Lead Sponsor
- Evotec Neurosciences GmbH
- Brief Summary
The purpose of this study is to determine whether a compound known as EVT 201 is effective in treating people diagnosed with primary insomnia ( difficulty sleeping with no other significant contributing factor, such as depression).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- must have a diagnosis of primary insomnia
- over the last three months, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours
- must be able to attend the Sleep Center for two consecutive nights on four occasions over a two month period
- must be willing and able to complete a sleep diary and questionnaires
Exclusion Criteria
- must not have a clinically significant or unstable medical condition that may interfere with sleep
- must not have a major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder
- must not be currently using any medication know to affect sleep e.g. hypnotics, anxiolytics,antidepressants, antihistamines, anticonvulsants
- must not intentionally nap 3 (or more) times per week
- must not smoke more than 10 cigarettes per day and /or be able not to smoke without distress or discomfort for the duration of visits to the sleep laboratory ( i.e. approximately 12 hours)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Total Sleep Time Wake after sleep onset
- Secondary Outcome Measures
Name Time Method REM latency Patient reported sleep variables Latency to persistent sleep Total wake time Minutes of stages 1-4 and REM sleep Number of awakenings Safety assessments including adverse events, ECgs, vital signs and routine laboratory assessments. Residual sedation measures
Trial Locations
- Locations (5)
St Petersburg Sleep Disorders Center
🇺🇸St Petersburg, Florida, United States
The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548
🇺🇸Atlanta, Georgia, United States
Vince and Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
St. Luke's Hospital
🇺🇸Chesterfield (St Louis), Missouri, United States
Tri-State Sleep Disorders Center
🇺🇸Cincinnati, Ohio, United States
St Petersburg Sleep Disorders Center🇺🇸St Petersburg, Florida, United States